Device product
Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
Z-1639-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,000 kits
- Official record key
device-enforcement:Z-1639-2017
Official wording
Reason: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Code information: 034435B Exp Date 2018-6-21; 037051B Exp Date 2018-6-21; 037462B Exp Date 2018-07-29; 038293B Exp Date 2018-08-17; 038779B Exp Date 2018-09-21; 039465B Exp Date 2018-10-10; 040093B Exp Date 2018-11-09;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field